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Regulatory Affairs Registration Manager - Belgium  

Keyrus Biopharma (company)

Posted on : 15 April 2017

Project Description

Job Description
  • We are looking for a Regulatory Affairs Registration Manager in Pharmaceuticals sector, being responsible for the maintenance of the worldwide product licences.  
  • The RA Registration Manager will ensure the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports, New Dossier requests etc & 

Primary Tasks & Responsibilities: 
  • Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
  • Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fulfilled
  • Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
  • Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
  • Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are met
  • Maintain close contacts with the Local Operating Compagnes s (LOC s) to ensure shared objectives are achieved
  • Ensure the tracking of relevant correspondence with Authorities and Local Operating Companies (LOCs) in archiving database (TRAC-IT)
  • Communicate with external regulators on specific enquiries
    • Communicate regulatory updated information to internal stakeholders
    • Participate in (or lead) the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow Company procedures appropriately.
    • Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise
  • Be responsible for Product Registration activities of one or several projects
  • Identify key issues on registration activities that could prevent achieving objectives and pro-actively propose solutions.  

  • University degree (preferably biological/chemical)  

Hard/Technical Skills: 
  • Ideally more than 2 years experience in the pharmaceutical industry including 1 year RA experience.
  • Knowledge of Regulatory legislation in at least one geographic area
  • Basic understanding of biologicals
  • Fluent in English; French is an asset
  • MS Office suite (Word, Excel, PPT)  

Soft skills :  
  • Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline
  • Integrity
  • Analytical capacity
  • Good organizational skills
  • Flexible work approach; enjoys a varied working day
  • Teamwork and collaboration
  • Customer oriented
  • Can work under stress and to deadlines
  • An eye for detail  

What We offer
  • You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization &).
  • Each employee will be welcomed with a varied integration program. 
  • We invest considerable time and resources in training our staff (technical and non-technical courses). 
  • You will join a dynamic and international environment with enthusiastic and professional colleagues.

Who We are
Our company is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs, and medical writing.

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